실용적 임상연구에 대한 이해와 적용을 위한 연구 사례 분석

윤영주,강경원,최선미 대한침구의학회 2009 대한침구의학회지 Vol.26 No.5

The use of acupuncutre has been increased worldwide, and large number of researches on acupuncture with improved quality has been conducted. Nevertheless, results of acupuncture treatment in those research tend to show mixed results, while many patients continuously seek acupuncture treatment as an adjuvant or alternatives for their health. Researchers and clinicians relevant to acupuncture are faced at this problematic discrepancy between the results of acupuncture in clinical trial including an randomized controlled trial and those of day-to-day clinical practice. The methodology of pragmatic clinical trial seems to be one of the promising research tools administering this problem especially in the area of complementary alternative medicine and traditional Korean medicine. In this study we first reviewed articles on the pragmatic clinical trial, summarized the essential concepts of ‘explanatory’ clinical trial ‘pragmatic’ clinical trial and then presented recent recommendations and arguments on this issue. We also analyzed and compared two similar pragmatic clinical trial protocols to show the readers the complexity of research designing. We hope more researchers in traditional Korean medicine will be interested in the methodology of pragmatic clinical trials and this study will serve to produce various high-quality clinical trials.

Effectiveness of Pharmacopuncture Therapy in Adhesive Capsulitis: a Study Protocol for a Pragmatic Randomized Controlled Trial

Zhao Hui Yan,Han Chang-Hyun,Yang Changsop,Lee Yoon Jae,Ha In-Hyuk,Park Kyoung Sun 사단법인약침학회 2023 Journal of Acupuncture & Meridian Studies Vol.16 No.2

Background: Adhesive capsulitis is a progressive, idiopathic disorder that significantly impacts individuals̓ daily lives and increases their medical burden. Pharmacopuncture therapy, which combines acupuncture techniques with herbal medicine, involves injecting herbal extracts into specific acupoints. This study aims to determine the effectiveness and safety of pharmacopuncture therapy in comparison to physiotherapy (PT) for treating adhesive capsulitis. Methods: This research protocol outlines a two-arm, parallel, multi-center, pragmatic randomized controlled trial. Fifty participants will be randomly allocated to either the pharmacopuncture therapy or PT group, and they will receive 12 sessions of their respective therapies over a 6-week period. The primary outcome measure is the numeric rating scale for shoulder pain. Secondary outcomes include the visual analog scale score for shoulder pain, Shoulder Pain and Disability Index, Patients̓ Global Impression of Change score, Short Form-12 Health Survey Version 2 score, and EuroQol-5 Dimension. Statistical analysis will be conducted based on the intention-to-treat principle. Discussion: This trial may offer high-quality and reliable clinical evidence for evaluating the effectiveness and safety of pharmacopuncture therapy compared to PT in the treatment of adhesive capsulitis. Furthermore, this study will serve as a valuable guideline for practitioners when making clinical decisions and managing adhesive capsulitis.

Add-on Effect and Safety of Pharmacopuncture Therapy in the Treatment of Patients with Lumbar Spinal Stenosis

Oh Yoona,Han Chang-Hyun,Kim Yeonhak,Kim Jihun,Yang Changsop,Choi Young Eun,Kang Byoung-Kab,Yang Gi Young,Lee Byung Ryul,Kim Eunseok 사단법인약침학회 2023 Journal of Acupuncture & Meridian Studies Vol.16 No.1

Background: Recently, Korean Medicine treatment with pharmacopuncture therapy (PPT) has been increasingly used in clinical practice to improve symptoms in patients with lumbar spinal stenosis (LSS). The aim of this study is to evaluate the effectiveness and safety of PPT in addition to conventional Korean Medicine treatment (CKMT) for the treatment of patients with LSS, compared with CKMT alone. Methods: This study is designed as a pragmatic, randomized, two-armed, parallel, stratified (by sex), controlled pilot trial. Forty patients diagnosed with LSS will be randomly allocated to the PPT + CKMT group or the CKMT group. Patients in the two groups will receive treatment two times weekly for 5 weeks. The primary outcome will be the mean change in the 100-mm visual analog scale score from the baseline to the end of treatment (week 5). The secondary outcomes will include the clinically important difference, Zurich Claudication Questionnaire score, self-reported walking capacity, Modified–Modified Schober test, EuroQol 5-dimension 5-level questionnaire, and Patients’ Global Impression of Change. Adverse events will be assessed at each visit. Discussion: The results of this study will provide meaningful data to evaluate the add-on effect and safety of PPT in the medical care of patients with LSS.

Improving Therapeutic Interventions of Schizophrenia with Advances in Stem Cell Technology

José Andrés Espejo Oltra 대한정신약물학회 2020 CLINICAL PSYCHOPHARMACOLOGY AND NEUROSCIENCE Vol.18 No.3

Although historic documents posit schizophrenia to the beginnings of mankind, its diagnosis remains poorly defined, currently relying on unspecific clinical symptoms; and controversies still maintain its origin under intense debate. This review aimed at quantitatively assessing the preferential forefronts of clinical trials towards the treatment of schizophrenia from inception till present, according to clinicaltrials.gov database registry. Towards that end study status and study phase classifications were used as criteria for progress in the field. Study groups by sex and age together with countries and organisms involved in the studies were used as indicators of the populations studied and as evidence of main promoter institutions, in both, pharmacological and drug-free protocols. The findings clearly show a decline of active clinical research with small synthetic compounds and limited numbers of novel initiatives, mostly based on drug-free alternatives with expected reduced secondary effects. A paucity of sex- and age-oriented designs is detected, and it is proposed that future clinical trials should set their basis on data obtained from patient-derived induced pluripotent stem cells, brain organoid systems and human brain circuitry platforms. Only individual precision medical approaches may turn effective for the treatment of this complex and highly incapacitating disease.

Intertextual Practice in Death Trials and Pragmatic Functions

Orawee Bunnag,Krisda Chaemsaithong 한국영어학회 2023 영어학 Vol.23 No.-

Adopting a discourse-pragmatic perspective, this study explores the intertextual practice of speech reporting in the context of capital trials, with an aim to propose a typology of the common pragmatic functions accomplished by incorporated voices. Based on the closing statements of five capital cases, the analysis reveals that, regardless of their orientation, opposing lawyers use external voices to support their stance on a death sentence. Four major functions of speech reporting are identified for this genre: narrating, contextualizing, deconstructing, and legitimizing. The reanimation of these voices not only allows lawyers to create different versions of facts and negotiate polarized perceptions of the person on trial but also contributes to making the closing speech genre highly heteroglossic and dialogic.

소아 알레르기 질환의 임상역학적 연구 설계

양현종 ( Hyeon Jong Yang ) 대한천식알레르기학회(구 대한알레르기학회) 2016 Allergy Asthma & Respiratory Disease Vol.4 No.2

Clinical epidemiology is defined as a method for investigating the distribution and determinants of diseases and for applying this knowledge in their prevention, and simply means application of epidemiological methods for medical research. In evidence-based medicine, randomized controlled trials (RCT) are the gold standard for assessing efficacy and safety of the intervention, while it is commonly impractical because of many limitations, such as ethical/legal problems and weak external-validity. High internal-validity of RCT permits to assess the direct efficacy of intervention without interference with bias and confounder; however, it has less generalizability or applicability to the real-life practice. Evidence-based practical guidelines are developed for patient management and decision making in real-life practice; paradoxically, the evidence of the guidelines does not come from real life, but from strict trial life. To overcome these limitations, pragmatic clinical trials for assessing the effectiveness of intervention in real-life practice or high-quality observational studies would be the best alternatives or could add more strong evidence. This article provides an overview of clinicoepidemiological research designs in the field of childhood allergic diseases and their strength/weakness. (Allergy Asthma Respir Dis 2016;4:91-99)

Artificial Intelligence for Improved Patient Outcomes—The Pragmatic Randomized Controlled Trial Is the Secret Sauce

Byrne Daniel W.,Domenico Henry J.,Moore Ryan P. 대한영상의학회 2024 Korean Journal of Radiology Vol.25 No.2

Effect and Safety of Combining Pharmacopuncture Therapy and Acupotomy in the Treatment of Patients with Degenerative Lumbar Spinal Stenosis: a Study Protocol for a Pragmatic, Assessor-Blinded, Randomized, Controlled Trial

Kim Jihun,Han Chang-Hyun,Kim Yeonhak,Lee Taewook,Yang Changsop,Choi Young Eun,Kang Byoung-Kab,Kim Kun Hyung,Yang Gi Young,Kim Eunseok 사단법인약침학회 2023 Journal of Acupuncture & Meridian Studies Vol.16 No.6

Background: Pharmacopuncture therapy and acupotomy are commonly used in combination for Conventional Korean Medicine Treatments (CKMT) for the treatment of patients with lumbar spinal stenosis (LSS). The aim of this study is to evaluate the effect and safety of combining pharmacopuncture therapy and acupotomy in the treatment of LSS. Methods: This study is designed as a pragmatic, assessor-blinded, randomized controlled trial with two parallel arms in a 1:1 ratio. A total of 104 participants diagnosed with LSS will be randomly assigned to an experimental group (pharmacopuncture therapy and acupotomy in addition to CKMT) or a control group (only CKMT). Patients in both groups will receive treatment two times weekly for 6 weeks. The primary outcome will be the mean change on the 100-mm visual analog scale (VAS) from the baseline to the end of the treatment (week 6). The secondary outcomes will include the mean change in the 100-mm VAS from baseline to week 10 and week 14, respectively. Proportion of patients who achieve the clinically important difference, Zurich Claudication Questionnaire, Roland-Morris disability questionnaire, self-reported maxium walking distance, EuroQol 5-dimension 5-level, and Patients’ Global Impression of Change will also be assessed. Adverse events will be assessed at each visit. The outcomes will be measured for a total of 14 weeks, including a treatment period of 6 weeks and follow-up of 4, 8 weeks. Discussion: The results of this trial will confirm the effect and safety of combining pharmacopuncture therapy and acupotomy in the treatment of patients with LSS.

Effectiveness and Safety of Pharmacopuncture Therapy for Chronic Low Back Pain: A Study Protocol for a Pragmatic Randomized Controlled Trial

Youn Young Choi,Hwa Yeon Ryu,Jae Hui Kang,Hyun Lee Korean AcupunctureMoxibustion Medicine Society 2024 대한침구의학회지 Vol.41 No.2

Background: Low back pain (LBP) is a common musculoskeletal disorder worldwide, with a lifetime prevalence of up to 80%. Among nonsurgical treatments for chronic LBP, Korean medicine treatments are highly preferred, and pharmacopuncture therapy combining acupuncture and herbal medicine is widely used. However, no evidence-based study has focused on the use of various types of pharmacopuncture. Methods: The pragmatic randomized controlled clinical trial will include 44 participants; recruitment will start in July 2023. All participants will receive integrated Korean medicine treatment including acupuncture, cupping, and infrared therapy, and the intervention group will also receive pharmacopuncture. After 16 treatment sessions, twice a week for 8 weeks, follow-up assessments will be performed at week 9. As a pragmatic randomized controlled clinical protocol, the type, dose, and acupoints of acupuncture and pharmacopuncture are not determined in advance but are selected and recorded according to the clinical judgment of the Korean medicine doctor. Results: The primary outcome will be measured using a visual analog scale score, and the secondary outcomes include the Oswestry disability index, patient global impression of change, no worse than mild pain, and range of motion. Safety will be assessed by examining participants' self-reported adverse events and vital signs and conducting blood tests before and after the test. Conclusion: This study aims to provide clinical evidence of the effectiveness and safety of pharmacopuncture for chronic LBP.

The Impact of Long-acting Paliperidone in Reducing Hospitalizations and Clinical Severity in Recent Onset Schizophrenia: A Mirror-image Study in Real-world Clinical Setting

Vjekoslav Peitl,Branka Aukst Margetić,Branka Vidrih,Dalibor Karlović 대한정신약물학회 2022 CLINICAL PSYCHOPHARMACOLOGY AND NEUROSCIENCE Vol.20 No.1

Objective: Schizophrenia is a debilitating disease that disrupts the lives of many affected individuals and exerts a toll on the health system. Only few studies assessed once-monthly injectable formulation of paliperidone palmitate (PP-1M) and other long-acting antipsychotics in recent onset schizophrenia (ROS). To evaluate whether PP-1M is efficacious in reducing frequency and length of hospitalizations and psychosis symptom severity in patients with ROS. Methods: This mirror-image study included 112 patients, suffering from ROS admitted in a psychiatric ward and successively treated with PP-1M for 1-year. Other psychotic disorders were excluded. We collected socio-demographic data of all subjects included, number and days of hospitalization, as well as Clinical Global Impression-Severity scale (CGI-S) and Clinician-Rated Dimensions of Psychosis Symptom Severity (CRDPSS) scores at the initiation and after 1-year of PP treatment. Results: After 1-year PP-1M treatment, mean scores of both CGI and CRDPSS significantly decreased (p < 0.001), as well as the mean number of hospitalizations (p = 0.002) and total hospitalization days (p < 0.001) in comparison with those of the previous year. Conclusion: Our results suggest that PP-1M can be considered as an important therapeutic option in patients with ROS. Its use led to a meaningful reduction in the patient’s use of hospital services, as well as a significant clinical improvement of psychotic symptoms in our sample.